Compliance Statement C: For human genetic inheritable conditions and mutations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

A completed Exome Sequencing consent form, signed by the patient (or legal guardian), and a completed patient history form for exome testing is required for all specimens. Samples should also be collected from both parents and any affected siblings and Exome Sequencing, Familial Control (ARUP Test Code 2006340) ordered to aid interpretation of patient's result. A separate patient history form should be completed for each control detailing their health history. For each parental or family member's specimen, please indicate on the test requisition form that the sample is a control and reference the patient's name.

* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

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